Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver Transplantation: The Phase II SATURN study
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Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver Transplantation: The Phase II SATURN study. / Forns, Xavier; Berenguer, Marina; Herzer, Kerstin; Sterneck, Martina; Donato, Maria Francesca; Andreone, Pietro; Fagiuoli, Stefano; Cieciura, Tomasz; Durlik, Magdalena; Calleja, Jose Luis; Mariño, Zoe; Shukla, Umesh; Verbinnen, Thierry; Lenz, Oliver; Ouwerkerk-Mahadevan, Sivi; Peeters, Monika; Janssen, Katrien; Kalmeijer, Ronald; Jessner, Wolfgang.
in: TRANSPL INFECT DIS, Jahrgang 19, Nr. 3, 06.2017, S. UNSP e12696.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver Transplantation: The Phase II SATURN study
AU - Forns, Xavier
AU - Berenguer, Marina
AU - Herzer, Kerstin
AU - Sterneck, Martina
AU - Donato, Maria Francesca
AU - Andreone, Pietro
AU - Fagiuoli, Stefano
AU - Cieciura, Tomasz
AU - Durlik, Magdalena
AU - Calleja, Jose Luis
AU - Mariño, Zoe
AU - Shukla, Umesh
AU - Verbinnen, Thierry
AU - Lenz, Oliver
AU - Ouwerkerk-Mahadevan, Sivi
AU - Peeters, Monika
AU - Janssen, Katrien
AU - Kalmeijer, Ronald
AU - Jessner, Wolfgang
N1 - © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2017/6
Y1 - 2017/6
N2 - BACKGROUND: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival.METHODS: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24 weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT).RESULTS: High rates of both on-treatment and sustained virologic response 12 weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naïve or had failed post-OLT treatment with peginterferon and RBV. Overall, 91% of patients (32/35) achieved SVR12. The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of SMV or DCV separately. Co-administration of SMV with cyclosporine resulted in significantly increased SMV plasma exposures, which was not the case with the co-administration of SMV with tacrolimus. Therefore, the concomitant use of SMV with cyclosporine is not recommended.CONCLUSION: The interferon-free combination of SMV, DCV, and RBV administered for 24 weeks was shown to be effective and well tolerated in the treatment of post-OLT HCV GT1b-infected patients.
AB - BACKGROUND: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival.METHODS: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24 weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT).RESULTS: High rates of both on-treatment and sustained virologic response 12 weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naïve or had failed post-OLT treatment with peginterferon and RBV. Overall, 91% of patients (32/35) achieved SVR12. The combination was generally well tolerated, with an adverse event profile consistent with that observed in previous clinical trials of SMV or DCV separately. Co-administration of SMV with cyclosporine resulted in significantly increased SMV plasma exposures, which was not the case with the co-administration of SMV with tacrolimus. Therefore, the concomitant use of SMV with cyclosporine is not recommended.CONCLUSION: The interferon-free combination of SMV, DCV, and RBV administered for 24 weeks was shown to be effective and well tolerated in the treatment of post-OLT HCV GT1b-infected patients.
KW - Journal Article
U2 - 10.1111/tid.12696
DO - 10.1111/tid.12696
M3 - SCORING: Journal article
C2 - 28295849
VL - 19
SP - UNSP e12696
JO - TRANSPL INFECT DIS
JF - TRANSPL INFECT DIS
SN - 1398-2273
IS - 3
ER -